Byetta Diabetes Type 2 Treatment - Byetta, Patient Information

Brand Names: Byetta
Generic Name: exenatide (ex EN a tide)

Byetta, Exenatide, full prescribing information

What is Byetta and what is it used for?

Byetta (exenatide) is an injectable diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin more efficiently.

Byetta is used to treat type 2 (non-insulin dependent) diabetes. Other diabetes medicines are sometimes used in combination with Byetta if needed.

Byetta may also be used for other purposes not listed in this medication guide.

Important information you need to have about Byetta

Do not use Byetta to treat type 1 (insulin-dependent) diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Before using Byetta, tell your doctor if you use any of these oral diabetes medications: acetohexamide (Dymelor), chlorpropamide (Diabinese), glimepiride (Amaryl), glipizide (Glucotrol), glyburide (DiaBeta), tolazamide (Tolinase), tolbutamide (Orinase).

You must use this medication within 60 minutes (1 hour) before eating a meal. If you miss a dose, use the medication as soon as you remember, but only if you have not yet eaten a meal. If you have already eaten a meal, wait until your next scheduled dose (1 hour before a meal) to use the medicine. Your Byetta doses should be spaced at least 6 hours apart. Do not use this medicine after eating a meal.

Stop using Byetta and call your doctor at once if you have severe pain in your upper stomach spreading to your back, with nausea, vomiting, and a fast heart rate. These could be symptoms of pancreatitis.

It is important to use Byetta regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

To be sure this medication is helping your condition, you will need to check your blood sugar at home. Your blood will also need to be tested by your doctor on a regular basis. Do not miss any scheduled appointments.

If you are using any type of antibiotic or birth control pill, take these medicines at least 1 hour before you use Byetta.

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Before you take Byetta

Do not use Byetta to treat type 1 (insulin-dependent) diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use Byetta:

• kidney disease (or if you are on dialysis);
• problems with digestion; or
• severe stomach disorders (gastroparesis).

FDA pregnancy category C. It is not known whether Byetta is harmful to an unborn baby. Before using Byetta, Tell your doctor if you are pregnant or if you become pregnant during treatment. It is not known whether exenatide passes into breast milk or if it could be harmful to a nursing baby. Do not take Byetta without telling your doctor if you are breast-feeding a baby.

How should I use Byetta?

Use Byetta exactly as it was prescribed for you. Donot use the medication in larger amounts or use it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication. Your dose needs may change if you are ill, if you have a fever or infection, or if you have surgery or a medical emergency. Do not change your dose of Byetta without first talking to your doctor. Use only the diabetes medications prescribed for you.

Byetta is given as an injection under the skin, usually in the upper thigh, stomach area, or upper arm. Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject this medicine. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Byetta is usually injected twice a day, before the morning and evening meal. You must use this medication within 60 minutes (1 hour) before eating the meal. Your Byetta doses should be given at least 6 hours apart. Do not use this medicine after eating a meal.

It is important to use Byetta regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Byetta comes in a prefilled pen with a "Pen User Manual" showing instructions for using the pen and injecting the medicine. You must do a "New Pen Set-Up" one time only, when starting a new prefilled Byetta Pen. If you do this "New Pen Set-Up" before each injection, you will run out of medicine before 30 days.

Pen needles are not included with this medicine. Ask your doctor, diabetes counselor, or pharmacist which needle size is best for you.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

To be sure this medication is helping your condition, you will need to check your blood sugar at home. Your blood will also need to be tested by your doctor on a regular basis. Do not miss any scheduled appointments.

Store unused Byetta injection pens in the refrigerator, protected from light. Do not freeze them, and throw away any pens that have become frozen. After your first use of a pen, it may then be stored at room temperature, away from heat and bright light.

Use the pen for only 30 days and then throw it away, even if it still has medicine in it. Do not use the medicine after the expiration date on the label has passed. Do not store the Byetta pen with the needle attached.

If the needle is left on, medicine may leak from the pen or air bubbles may form in the cartridge. Keep your Byetta pen, pen needles, and all medicines out of the reach of children.

What happens if I miss a dose?

Use the missed dose as soon as you remember, but only if you have not yet eaten a meal. If you have already eaten a meal, wait until your next scheduled dose (1 hour before a meal) to use the medicine. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose can cause severe nausea and vomiting, or signs of low blood sugar (headache, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and tremor).

What should I avoid while using Byetta?

Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.

If you are using any type of antibiotic or birth control pill, take these medicines at least 1 hour before you use Byetta.

Byetta side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Byetta and call your doctor at once if you have severe pain in your upper stomach spreading to your back, with nausea, vomiting, and a fast heart rate. These could be symptoms of pancreatitis.

Less serious Byetta side effects may include:

• nausea, vomiting, heartburn, diarrhea;
• loss of appetite;
• weight loss; or
• dizziness, headache, or feeling jittery.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them:

• hunger, headache, confusion, irritability;
• drowsiness, weakness, dizziness, tremors;
• sweating, fast heartbeat;
• seizure (convulsions); or
• fainting, coma (severe hypoglycemia can be fatal).

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Byetta?

Before using Byetta, tell your doctor if you use any oral (taken by mouth) diabetes medications. You may need a dose adjustment:

• acetohexamide (Dymelor);
• chlorpropamide (Diabinese);
• glimepiride (Amaryl);
• glipizide (Glucotrol);
• glyburide (DiaBeta);
• tolazamide (Tolinase); or
• tolbutamide (Orinase).

Your doctor will tell you if any of your medication doses need to be changed.

There may be other drugs that can interact with Byetta. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about Byetta.
• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

last updated 09/2007

Byetta, Exenatide, full prescribing information

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